Roche's MabThera Maintains EU Approval, Commercialized for 27 Years Amid Biosimilar Competition
EU Approval and Regulatory History
The European Medicines Agency (EMA) continues to maintain Roche's MabThera (active ingredient: rituximab) as a marketed medicinal product across the EU. The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on January 28, 1998, and the European Commission granted the initial marketing authorization on June 2, 1998. In the U.S., it was approved under the brand name Rituxan by the FDA on November 26, 1997. This information highlights the significance of 27 years of accumulated efficacy and safety data, as well as the ongoing post-marketing risk management system, rather than a new approval.
CD20 Targeting and Approved Indications
Rituximab is a chimeric monoclonal antibody that binds to CD20 on the surface of normal and malignant B cells, inducing B-cell depletion. Its EU-approved indications include follicular lymphoma, diffuse large B-cell lymphoma (DLBCL), chronic lymphocytic leukemia, as well as rheumatoid arthritis, angioedema with eosinophilia, microscopic polyangiitis, and moderate to severe pemphigus vulgaris. In hematological malignancies, it is used as monotherapy, maintenance therapy, or in combination with CHOP-based chemotherapy, while in rheumatoid arthritis, it is combined with methotrexate. The fact that a single target bridges oncology and immunological diseases has contributed to the product's long lifecycle and broad prescribing base.
Biosimilars and Therapeutic Competition
In Europe, Celltrion's Truxima (rituximab) received approval on February 17, 2017, and Sandoz's Rixathon (rituximab) on June 15, 2017, intensifying price and tender competition. Both products are CD20 biosimilars referencing MabThera and serve as direct clinical substitutes. In DLBCL, R-CHOP including rituximab remains the core treatment, while Pola-R-CHP including Roche's Polivy (polatuzumab vedotin, a CD79b-targeting antibody-drug conjugate) is also competing in new patient populations. Therefore, factors such as hospital tendering, biosimilar switch rates, and the convenience of subcutaneous formulations are more decisive in protecting the original product than the mere maintenance of approval.
Market Potential and Investment Implications
Market research firm OG Analysis estimates the global rituximab biosimilar market to reach USD 3.9 billion in 2025 and USD 11.7 billion in 2034. Roche's 2025 revenue from MabThera and Rituxan is CHF 1.251 billion, combining CHF 962 million in hematological cancers and CHF 289 million in immunological diseases, a decline from CHF 1.379 billion in 2024. This reflects a typical mature asset trend where biosimilar penetration and price erosion are progressing, not due to clinical demand exhaustion. While it remains a stable cash-generating asset for Roche, it is not a growth driver. For patients and healthcare systems, it provides a foundation for improving CD20 treatment accessibility and cost efficiency.
MabThera, approved in the EU in 1998, is a CD20-targeting antibody that has been marketed for 27 years, setting clinical, manufacturing, and pharmacovigilance benchmarks in hematological malignancies and autoimmune diseases. Roche's 2025 revenue from MabThera and Rituxan is CHF 1.251 billion, down from CHF 1.379 billion in 2024, while the global rituximab biosimilar market is estimated at USD 3.9 billion in 2025, showing simultaneous expansion in treatment demand and price competition. In the short term, the hospital tendering expansion of Truxima and Rixathon is pressuring original sales and pricing, and treatment choice shifts between R-CHOP and Pola-R-CHP in DLBCL also affect usage. For researchers, it serves as a long-term real-world safety data reference and a comparative benchmark for CD20-based combination strategies. For the industry, it is a case study in managing the lifecycle of a mature antibody and verifying biosimilar commercialization capabilities. From an investment perspective, the key concern is ongoing revenue erosion rather than clinical failure risk, making the outlook neutral. The extent to which Roche's follow-on hematological oncology portfolio, such as Polivy and Gazvya, can offset the decline will be a key mid-to-long-term evaluation factor.
Source: EMA (ema)